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一种用于确定新型冠状病毒肺炎(COVID-19)研究性治疗评估优先级的创新工具:一个试点项目。

An innovative tool to prioritize the assessment of investigational COVID-19 therapeutics: A pilot project.

作者信息

Béïque Lizanne, Clarke Savannah, Azad Mina, Sarwar Elaha, Gale-Rowe Margaret, Sabourin Stacy, Marinsky Cheryl, Arthur Jacqueline

机构信息

Infectious Diseases and Vaccination Programs Branch, Public Health Agency of Canada, Ottawa, ON.

出版信息

Can Commun Dis Rep. 2024 Oct 3;50(10):357-364. doi: 10.14745/ccdr.v50i10a04. eCollection 2024 Oct.

DOI:10.14745/ccdr.v50i10a04
PMID:39380802
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11460842/
Abstract

BACKGROUND

As the COVID-19 pandemic unfolded, hundreds of investigational COVID-19 therapeutics emerged. Maintaining situational awareness of this extensive and rapidly evolving therapeutic landscape represented an unprecedented challenge for the Public Health Agency of Canada, as it worked to promote and protect the health of Canadians. A tool to triage and prioritize the assessment of these therapeutics was needed.

METHODS

The objective was to develop and conduct an initial validation of a tool to identify investigational COVID-19 therapeutics for further review based on an efficient preliminary assessment, using a systematic and reliable process that would be practical to validate, implement and update. Phase 1 of this pilot project consisted of a literature search to identify existing COVID-19 therapeutic assessment prioritization tools, development of the Rapid Scoring Tool (RST) and initial validation of the tool.

RESULTS

No tools designed to rank investigational COVID-19 therapeutics for the purpose of prioritizing their assessment were identified. However, a few publications provided criteria to consider and therapeutic ranking methods, which helped shape the development of the RST. The RST included eight criteria and several descriptors ("characteristics"). A universal characteristic scoring scale from -10 to 10 was developed. The sum of all the characteristic scores yielded an overall benefit score for each therapeutic. The RST appropriately ranked therapeutics using a systematic, reliable and practical approach.

CONCLUSION

Phase 1 was successfully completed. The RST presents several distinct aspects compared with other tools, including its scoring scale and method, and capacity to factor in incomplete or pending information. It is anticipated that the framework used for the RST will lend itself to use in other dynamic situations involving many interventions.

摘要

背景

随着新冠疫情的发展,数百种新冠病毒研究性疗法涌现出来。对于致力于促进和保护加拿大民众健康的加拿大公共卫生署而言,要时刻掌握这一广泛且迅速演变的治疗领域的情况,是一项前所未有的挑战。因此需要一种工具来对这些疗法的评估进行分类并确定优先顺序。

方法

目标是开发并初步验证一种工具,该工具基于高效的初步评估,通过系统且可靠的流程来识别新冠病毒研究性疗法,以便进一步审查,且该流程在验证、实施和更新方面具有实际可行性。该试点项目的第一阶段包括文献检索以识别现有的新冠病毒治疗评估优先排序工具、开发快速评分工具(RST)以及对该工具进行初步验证。

结果

未发现专门用于对新冠病毒研究性疗法进行排名以确定评估优先顺序的工具。然而,一些出版物提供了需要考虑的标准和治疗排名方法,这有助于RST的开发。RST包括八个标准和几个描述符(“特征”)。制定了一个从-10到10的通用特征评分量表。所有特征分数的总和得出每种疗法的总体效益分数。RST使用系统、可靠且实用的方法对疗法进行了合理排名。

结论

第一阶段已成功完成。与其他工具相比,RST有几个不同的方面,包括其评分量表和方法,以及纳入不完整或待决信息的能力。预计RST所使用的框架将适用于涉及多种干预措施的其他动态情况。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5506/11460842/5dc11ea4a556/501004-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5506/11460842/b247fa57fbb2/501004-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5506/11460842/5dc11ea4a556/501004-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5506/11460842/b247fa57fbb2/501004-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5506/11460842/5dc11ea4a556/501004-f2.jpg

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